US FDA’s Precision Medicine Efforts Turn Towards Adverse Events
Next PrecisionFDA challenge aims to detect ‘adverse event anomalies’ including manufacturer-specific patterns and drug-drug interactions.
You may also be interested in...
Commissioner Scott Gottlieb's statement noting the limitations of FAERS comes just four days after he was quoted in an FDA announcement about the launch of a more searchable portal for the adverse event database.
At White House summit on precision medicine, President Obama emphasized the need to break down outmoded regulations, and suggested barriers between drug and device oversight need to be loosened; FDA and NIH announced a number of new competitions and projects.
Pink Sheet reporter and editors examine the struggle over the FDA’s reputation, whether a coronavirus vaccine could be made available without sponsor cooperation, and the late Supreme Court Justice Ruth Bader Ginsburg’s legacy for pharma.